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Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02305017
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : November 18, 2015
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Tracking Information
First Submitted Date  ICMJE November 28, 2014
First Posted Date  ICMJE December 2, 2014
Results First Submitted Date  ICMJE July 22, 2015
Results First Posted Date  ICMJE November 18, 2015
Last Update Posted Date November 18, 2015
Study Start Date  ICMJE March 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2015)
Cmax - Maximum Plasma Concentration [ Time Frame: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose ]
Cmax - Maximum plasma concentration of opicapone on Day 12 following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2014)
Cmax - maximum observed plasma concentration [ Time Frame: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2015)
  • Tmax - Time of Occurrence of Cmax [ Time Frame: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose ]
    Tmax - time of occurrence of Cmax following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.
  • AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification [ Time Frame: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose ]
    AUC0-t - area under the plasma concentration-time curve (AUC) from time zero to the last sampling time following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration
  • AUC0-∞ - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity. [ Time Frame: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose ]
    AUC0-∞ - AUC from time 0 to infinity following an oral single-dose of 50 mg OPC administered alone or 1.5 h after last 1 g Paracetamol administration.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2014)
  • Tmax - Time of Occurrence of Cmax [ Time Frame: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose ]
  • AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification [ Time Frame: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose ]
  • AUC0-24 - AUC from time zero to 24 hours post-dose [ Time Frame: before and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hour post-OPC dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers
Official Title  ICMJE Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy Volunteers
Brief Summary Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods separated by a washout period of 14 days or more.
Detailed Description Single-centre, open-label, randomised, two-way cross-over study consisting of 2 periods separated by a washout period of 14 days or more. In one period, subjects received three single-doses of 1 g paracetamol separated by 6 hours and 1.5 hours after the last paracetamol dose a single-dose of 50 mg OPC was administered.In the other period, a single-dose of 50 mg OPC was administered alone.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Drug: BIA 9-1067
    BIA 9-1067 50 mg
    Other Name: OPC, Opicapone
  • Drug: Paracetamol
    Paracetamol 1g
    Other Name: acetaminophen
Study Arms  ICMJE
  • Experimental: Period 1 OPC + Paracetamol; Period 2 OPC
    Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)
    Interventions:
    • Drug: BIA 9-1067
    • Drug: Paracetamol
  • Experimental: Period 1 OPC; Period 2 OPC+ Paracetamol
    Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;
    Interventions:
    • Drug: BIA 9-1067
    • Drug: Paracetamol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 28, 2014)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who are able and willing to give written informed consent.
  • Male or female subjects aged between 18 and 45 years, inclusive.
  • Subjects of body mass index (BMI) between 19.0 and 30.0 kg/m2, inclusive.
  • Subjects who are healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
  • Subjects who have negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.
  • Subjects who have clinical laboratory test results clinically acceptable at screening and admission to each treatment period.
  • Subjects who have a negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.
  • Subjects who are non-smokers or ex-smokers for at least 3 months.
  • (If female) She is not of childbearing potential by reason of surgery or, if of childbearing potential, she uses an effective non-hormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap [diaphragm or cervical or vault caps] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he is the sole partner of that subject) for all the duration of the study.
  • (If female) She has a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period.

Exclusion Criteria:

  • Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
  • Subjects who have a clinically relevant surgical history.
  • Subjects who have any clinically relevant abnormality in the coagulation tests.
  • Subjects who have any clinically relevant abnormality in the liver function tests (a case-by-case decision for any abnormality must be discussed with the Sponsor before inclusion).
  • Subjects who have a history of relevant atopy or drug hypersensitivity, particularly to paracetamol or any COMT inhibitor.
  • Subjects who have a history of alcoholism or drug abuse.
  • Subjects who consume more than 14 units of alcohol a week.
  • Subjects who have a significant infection or known inflammatory process at screening or admission to each treatment period.
  • Subjects who have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.
  • Subjects who have received paracetamol within 2 weeks of admission to the first period.
  • Subjects who have used any other medicines within 2 weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion.
  • Subjects who have previously received OPC.
  • Subjects who have used any investigational drug or participated in any clinical trial within 90 days prior to screening.
  • Subjects who have participated in more than 2 clinical trials within the 12 months prior to screening.
  • Subjects who have donated or received any blood or blood products within the 3 months prior to screening.
  • Subjects who are vegetarians, vegans or have medical dietary restrictions.
  • Subjects who cannot communicate reliably with the investigator.
  • Subjects who are unlikely to co-operate with the requirements of the study.
  • Subjects who are unwilling or unable to give written informed consent.
  • (If female) She is pregnant or breast-feeding.
  • (If female) She is of childbearing potential and she does not use an approved effective contraceptive method or she uses oral contraceptives.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02305017
Other Study ID Numbers  ICMJE BIA-91067-125
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bial - Portela C S.A.
Study Sponsor  ICMJE Bial - Portela C S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bial - Portela C S.A.
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP